Fludara Oral Film-Coated Tablets

FLUDARA ORAL is a medication that stops the growth of new cancer cells. All cells of the body produce new cells like themselves by dividing. To do this the cell’s genetic material (DNA) must be copied and reproduced. FLUDARA ORAL is taken up by the cancer cells and hinders the production of new DNA. FLUDARA ORAL is used in the treatment of B-cell chronic lymphocytic leukaemia (B-CLL) in patients with sufficient healthy blood cell production.

Your doctor will examine you and ask you about your medical history in order to decide whether you can take FLUDARA ORAL. Do not take FLUDARA ORAL:

• If you are allergic (hypersensitive) to fludarabine phosphate or any of the other ingredients of FLUDARA ORAL (see WHAT FLUDARA ORAL CONTAINS).
• If you have severely reduced kidney function.
• If the number of your red blood cells is reduced due to breaking down of these cells.

FLUDARA ORAL is not recommended for use in children under the age of 18 since it has not been established if it is safe in children and adolescents.

Take special care with FLUDARA ORAL:

• If your bone marrow is working very poorly, or if you have a poorly functioning or depressed immune system or a history of infections due to depressed immune system. Tell your doctor if any of the conditions listed above apply before your treatment. Your doctor may decide not to give you FLUDARA ORAL, or may give you some additional treatment.
• If you feel unwell, have unusual bruising, more bleeding than usual after injury, or if you seem to be catching a lot of infections. These may be signs of a reduction in the number of your blood cells, which may be caused either by the disease itself or the therapy. It can last for up to a year, independent of whether or not you had a treatment with FLUDARA ORAL before. You will have regular blood tests during treatment and you will be closely monitored while you are being treated with FLUDARA ORAL. Inform your doctor if any of these apply before you start treatment.
• If during treatment your urine turns red to brownish, or you have a rash or any blisters on your skin, inform your doctor immediately.

Do not share medicines prescribed for you with any other person. Always take FLUDARA ORAL exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.

FLUDARA ORAL can be taken either on an empty stomach or together with food. Swallow the tablets whole with water. Do not chew or break tablets.

How long the treatment with FLUDARA ORAL lasts depends on how successful it is, and how well you tolerate FLUDARA ORAL. If side effects are a problem, the repeat course may be delayed and/or the dosage may be decreased. You will have blood tests after every treatment course. Your individual dose will be carefully adjusted according to the number of your blood cells and your response to the therapy. If the number of your blood cells is too low, your next treatment cycle may be postponed for up to two weeks or your dose may be decreased.

Repeat treatment option after initial FLUDARA ORAL treatment: If you have responded well to FLUDARA ORAL once, you have a good chance of doing so again at a later stage.

How FLUDARA ORAL should be handled: Due to the toxic nature of an anti-cancer medication, such as FLUDARA ORAL, special protective recommendations for handling are advised. Please consult your doctor. FLUDARA ORAL must not be touched by pregnant women.

If you take more FLUDARA ORAL than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre.

FLUDARA ORAL can have side effects. Not all side effects reported for FLUDARA ORAL are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving FLUDARA ORAL, please consult your doctor qualified and experienced in the use of FLUDARA ORAL.

If any of the following happens, stop taking FLUDARA ORAL and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.
• Yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FLUDARA ORAL. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Symptoms of leukoencephalopathy, such as headache, feeling sick (nausea) and vomiting, visual disturbances including vision loss, changes in mental status (abnormal thinking, confusion, altered consciousness, agitation), drowsiness, muscle weakness in your limbs (including irreversible partial or complete paralysis), uncontrolled leakage of urine.
• Bleeding in the brain (with symptoms such as severe headache, difficulty speaking or walking, vision problems, confusion, seizures/fits).
• Inflammation of the bladder, which can cause pain when passing urine, and can lead to blood in the urine (haemorrhagic cystitis).
• Difficulty breathing, coughing associated with blood discharge, or chest pain with or without fever. These may be signs of lung problems.
• Palpitations (if you suddenly become aware of your heartbeat) or chest pain. These may be signs of heart problems.

These are all serious side effects. You may need urgent medical attention.

Store at or below 30 °C.

Do not remove from outer carton until required for use.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Do not use after the expiry date printed on the label or carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).